Back to resultsA Safety and Efficacy Study to Evaluate Wound Healing
Primary Purpose
Wound Heal
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AIV001
Sponsored by
About this trial
This is an interventional treatment trial for Wound Heal focused on measuring wound healing
Eligibility Criteria
Inclusion Criteria:
- Eligible for an abdominoplasty
- Nonsmoker
- Fitzpatrick I-IV
- Weight >45Kg
- BMI <= 35
Exclusion Criteria:
- Existing scars in study area, active infection
- Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
Sites / Locations
- Cosmetic Laser Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
0.033% versus Vehicle
0.1% versus Vehicle
0.3% versus Vehicle
1% versus Vehicle
Arm Description
One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.
One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.
One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.
One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.
Outcomes
Primary Outcome Measures
Adverse events
Local and systemic adverse events
Secondary Outcome Measures
Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)
Evaluation of the healing of the wounds
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
Evaluation of the healing wounds
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
Evaluation of healing wounds
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03639883
Brief Title
A Safety and Efficacy Study to Evaluate Wound Healing
Official Title
A Randomized, Double-blind, Vehicle-controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Intradermally Administered AIV001 in the Healing of Incisional Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AiViva BioPharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds
Detailed Description
This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal
Keywords
wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Randomized, double-blind, vehicle-controlled, dose-escalation
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.033% versus Vehicle
Arm Type
Placebo Comparator
Arm Description
One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.
Arm Title
0.1% versus Vehicle
Arm Type
Placebo Comparator
Arm Description
One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.
Arm Title
0.3% versus Vehicle
Arm Type
Placebo Comparator
Arm Description
One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.
Arm Title
1% versus Vehicle
Arm Type
Placebo Comparator
Arm Description
One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.
Intervention Type
Drug
Intervention Name(s)
AIV001
Other Intervention Name(s)
AIV001 suspension
Intervention Description
Intradermal injection
Primary Outcome Measure Information:
Title
Adverse events
Description
Local and systemic adverse events
Time Frame
Day 1 through Day 49
Secondary Outcome Measure Information:
Title
Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)
Description
Evaluation of the healing of the wounds
Time Frame
Day 7 through 49
Title
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)
Description
Evaluation of the healing wounds
Time Frame
Day 7 through 49
Title
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)
Description
Evaluation of healing wounds
Time Frame
Day 7 through 49
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eligible for an abdominoplasty
Nonsmoker
Fitzpatrick I-IV
Weight >45Kg
BMI <= 35
Exclusion Criteria:
Existing scars in study area, active infection
Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Milbauer, MD
Organizational Affiliation
Novella Clinical
Official's Role
Study Director
Facility Information:
Facility Name
Cosmetic Laser Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Efficacy Study to Evaluate Wound Healing
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